1. Field of the Invention
The present invention relates generally to the field of medical devices and, more specifically, to a handheld device that stimulates the meibomian gland of the eyelid both mechanically and thermally at the same time.
2. Description of the Related Art
Meibomian gland dysfunction, dry eye and chronic marginal eyelid inflammation are widespread problems, especially in middle age and geriatric populations worldwide. In fact, the problem is so widespread that this topic is covered in virtually every ophthalmic medical textbook and is the sole focus for groups of international researchers such as the Tear Film and Ocular Surface Society. The common cause of “dry eye” is not—as one might expect—a lack of watery substance in tears, but it is in most cases a lack of an oily substance in tears. Tears are a complex mix of substances from various glands located on and around the eye. These substances need to be in the correct balance in order to maintain the health of the eye and to preserve vision. The present invention deals with constant (or basal) tears and not with reflex tears (as in crying).
The tears of the eye are made from different elements. The majority of the tear film is thin fluid that comes from the lacrimal gland, which is located directly above the eye. The quantity and quality of this fluid is usually not the problem. The meibomian glands, which are located throughout both the upper and lower eyelids and number in the range of twenty per lid, secrete an oily material (lipids) that keeps the watery part of tears (i.e., the fluid secreted by the lacrimal gland), from evaporating. This material is normally secreted/expressed with each blink. It is the dysfunction of these glands that is the problem for most people who suffer from dry eye conditions.
In individuals with healthy tear secretion, the oily material secreted by the meibomian glands is relatively warm and runny. Like any oil, however, this material becomes more viscous as it cools. As the normal human ages, the outflow of the meibomian glands decreases, thereby reducing tear contact time and causing a marked decrease in tear quality. In some individuals with long-stand meibomian gland dysfunction, secretions may cease altogether. To some extent, this occurrence is due to the thinning of the skin and the cooling of the oily material in the glands due to loss of body heat. As a result, the oily material that should have the consistency of olive oil is instead semi-solid, like butter. When this happens, it is not easily secreted from the eyelid without being physically massaged (i.e., forced out as in squeezing toothpaste from a tube) and/or warmed up (to alter the consistency).
The most common treatment for this condition, referred to as meibomian gland disease or meibomianitis, consists of having the patient apply a warm, wet compress to the eye repeatedly until the lids are warm and pliable and then massaging the eye with the fingers or a homemade device such as a bag filled by uncooked rice grains. This procedure is messy and inconvenient and must be repeated daily in order to have the intended effects. Furthermore, it is difficult to achieve and maintain the optimum temperature. Physicians are also somewhat reluctant to use this technique for fear of an elderly patient burning himself or herself. Without an immediate improvement in symptoms, patients often become disenchanted and discontinue therapy.
There are various prescription and non-prescription medications, topical and oral, directed toward alleviating the effects of dysfunctional meibomian glands, and research efforts directed toward pharmaceutical solutions are ongoing. The appeal of the pharmaceutical remedies is that they do not require the patient to follow a lengthy daily regimen of heat and massage, but these remedies have thus far proven to be less effective, in most cases, than the heat-and-massage treatments. All pharmaceutical treatments for chronic conditions are problematic in the areas of drug allergies and sensitivities, interactions with other drugs and ongoing expense.
Additionally, surgical procedures have been developed using instruments to probe and express the meibomian glands. These procedures have been shown to offer some immediate results but are not practical for a patient to undergo on a weekly, monthly or sustained basis. This procedure also has to be done in a physician's office and with at least local anesthesia. It should be noted that all existing therapies are aimed at mid- to late-stage (symptomatic disease) and are augmented by the application of heat and massage.
For most people, once they develop meibomianitis, the condition lasts a lifetime. Untreated meibomian gland disease can lead to ocular infection and/or inflammation of the eyelids (referred to as posterior blepharitis). Posterior blepharitis, if untreated, can lead to corneal disease, which can lead to uncorrectable blurred vision and blindness in severe cases.
A number of devices have been invented that massage, heat and/or apply electrical microcurrent or sonic energy (which the present invention does not do) to various parts or the body, but none of them is specifically tailored to address the problem of meibomian gland disease. For example, U.S. Pat. No. 4,387,707 (Polikoff, 1983) discloses an eye treatment device that applies a fluctuating massaging force against the eye through a flexible wall in a chamber that contains a fluid maintained under a fluctuating pressure. This device does not involve heating of the eyelid.
U.S. Pat. No. 4,918,818 (Hsieh, 1990) describes a multi-purpose shaver with a face massaging component. In order to use the face massaging component, the razor holder is detached from the body of the device, and the face massaging component is attached to the body of the device where the razor holder had been. This device does not involve a heating element.
U.S. Pat. No. 6,275,735 (Jarding et al., 2001) involves an apparatus for electrical microcurrent stimulation therapy of a body part. This invention is intended to provide electrical microcurrent stimulation around an eye to combat visual system diseases such as age-related mascular degeneration (AMD). The inventors claim that microcurrent stimulation will help rejuvenate the cells in the retina to slow or stop degeneration of the eye due to AMD. This invention does not involve any kind of a plate over the eyelid, nor does it involve heating. In a preferred embodiment, the electrical microcurrent is applied with a probe tip comprised of a cotton swab moistened or dampened with a conductive gel.
U.S. Pat. No. 7,069,084 (Yee, 2006) discloses a method for treating meibomianitis by massaging the muscle fibers in the eyelid that express the meibomian gland. The device is intended to cause the meibomian glands to expel any obstructing plugs in the meibomian glands. According to the inventors, the obstructing plug may be composed of hardened lipids (as described above), cellular debris or some combination thereof. The invention involves the placement of electrical contacts on the eyelid and the application of an electrical current to the eyelids via the electrical contacts, which in turn induces muscular contractions within the eyelid. Unlike the present invention, this particular invention does not try to prevent the hardened lipids from occurring.
U.S. Pat. No. 7,122,013 (Liu, 2006) describes an eye massage device comprising a mask with left and right portions and left and right diaphragms in each eye portion. The mask is connected to a pneumatic-powered cylinder assembly via a plastic tube. The pneumatic-powered cylinder assembly comprises a cylinder that alternately delivers compressed air to the mask and draws air from the mask. In this manner, the eyes are massaged. In one embodiment, spacers are located between the diaphragms and the eyes as a means for absorbing tears secreted by the eyes during operation. This device is not handheld, and it does not provide heat to the eyelid.
U.S. Pat. No. 7,384,405 (Rhoades, 2008) involves a cosmetic instrument with a number of different interchangeable heads. These heads include abrasive attachments, oxygenating attachments, brush attachments, thermal attachments, and light radiating attachments. These various types of treatment attachments are moved over an area of skin and/or body part by the user manipulating the handle and also by a motion generator that moves the head portions. The motion generator may move the attachments by vibrating, spinning, oscillating, or propagating sonic waves through the head portions. The purpose of the thermal attachment is to facilitate the application of a cosmetic composition or solution onto the skin. The thermal attachment is moved over an area of skin or a body part in “upward circular or randomly directed strokes” until the composition or solution has been worked into, cleaned, and/or polished the skin or body part. This device is not specifically tailored for treatment of an eyelid disorder.
U.S. Pat. No. 7,637,878 (Lin, 2009) discloses an eye massaging device with built-in air pump and actuation elements, an inflatable fomentation member, and a belt member to which the main member and fomentation member are attached. The main member contains a number of slidably engaged pieces that elastically expand along with the belt member when the device is tied around a user's head. The fomentation member is shaped like an eyeshade and comprises a first outer piece, a second outer piece, an air bag and a thin heating element. The air pump and leakage valve inflate and deflate the air bag to press the warm heating element against the eyes with various levels of pressure. This device treats both eyes at once and would not be effective in treating a single eyelid.
U.S. Patent Application Pub. No. 2002/0156402 (Woog et al.) describes a device that applies sonic energy to various parts of the body for therapeutic purposes. The device comprises an applicator end at which a predetermined amplitude is generated under applied loads. This device does not involve massage or heating of the eyelid.
U.S. Patent Application Pub. No. 2008/0200848 (Avni) involves a vibrating device that the inventor claims may be applied directly to a closed eyelid. This invention does not involve the application of heat to the eyelid, and the application does not include a single figure showing what the device would look like as applied to the eyelid.
None of the above inventions combines both heat and massage to effectively treat meibomian gland disease. What is needed is a handheld device that is easy to use, mechanically configured for placement over an eyelid, and that accomplishes both the thermostatically controlled heating and massaging of the eyelid at the same time. Accordingly, it is an object of the present invention to provide a handheld, battery-operated device with an oscillating, curved plate (for placement over the eyelid) that has a thermostatically controlled heating element within it. The oscillating motion of the curved plate applies a massaging action to the eyelid, and the heater is preferably controlled to achieve the optimum temperature. The present invention simultaneously liquefies and mobilizes the lipids in the meibomian glands, thereby causing them to move toward the gland orifices. With regular use, these oils remain less viscous, and the tear quality improves.
Recent research has concluded that meibomianitis is a condition that affects a vast number of individuals; some authors cite numbers as high as thirty percent of the population at fifty years of age. Researchers also agree that the condition becomes more common with age, which means that the percentages increase with an aging population. The disease is asymptomatic for some period of time—months to years—but almost always progresses. Eye physicians are well aware of this fact and the need to begin treatment as early as possible to alleviate damage from chronic disease. The very fact that the disease, in its early stages, is asymptomatic, coupled with the fact that treatments to date have their drawbacks or contraindications, leads doctors to allow the condition to go untreated until it becomes symptomatic and damage is done. In the later stages of the disease, treatment is more complex, costly and less-effective. The present invention will allow physicians to direct patients to a treatment method that is noninvasive, simple to use, and should provide years of service without ongoing expense.
In addition to meibomian gland dysfunction, other more acute eyelid conditions, which can occur at any age, are treated with warm massage. They too could be treated with the present invention; such common conditions as hordeolum and chalazion fall into this category.